Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients - Full Text View

Purpose

The purpose of this study was to determine the effects of rosiglitazone in normotensive type 2 diabetic patients with regard to its blood-pressure–reducing effects.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: rosiglitazone(drug), blood pressure lowering effect	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study of PPAR Gamma Agonist-Rosiglitazone in Normotensive Type 2 Diabetics With Ambulatory Blood Pressure Monitoring

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by Baskent University:

Primary Outcome Measures:

Ambulatory blood pressure monitors used to determine the subjects blood pressure before and after the treatment. At the end of three months period wit rosiglitazone treatment diastolic blood pressure decreased.

Estimated Enrollment:	25
Study Start Date:	March 2004
Estimated Study Completion Date:	August 2004

Detailed Description:

The first study to evaluate the effects of troglitazone on blood pressure in humans was published recently, which demonstrated a 5/4 mm Hg reduction in ambulatory blood pressure in 18 nondiabetic obese subjects after 12 weeks’ treatment. Another study in 18 hypertensive subjects with diabetes mellitus showed an 18/12 mm Hg decline in office blood pressure after 8 weeks of treatment.

Eligibility

Ages Eligible for Study:	49 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Blood pressure of patients were in normotensive limits according to the JNC VII
Diabetes mellitus treated with oral antidiabetics or diet

Exclusion Criteria:

Any known hypertension, coronary artery disease, congestive hearth failure, renal disease or liver disease
Anti-hypertensive treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290394

Locations

Turkey
Baskent University Ankara Hospital
Ankara, Turkey, 06490

Sponsors and Collaborators

Baskent University

Investigators

Study Director:

Neslihan B Tutuncu, MD

Medical Doctor, Endocrynology

More Information

Publications:

Takano H, Komuro I. Roles of peroxisome proliferator-activated receptor gamma in cardiovascular disease. J Diabetes Complications. 2002 Jan-Feb;16(1):108-14. Review.

Walker AB, Naderali EK, Chattington PD, Buckingham RE, Williams G. Differential vasoactive effects of the insulin sensitizers rosiglitazone (BRL 49653) and troglitazone on human small arteries in vitro. Diabetes. 1998 May;47(5):810-4.

Fujishima S, Ohya Y, Nakamura Y, Onaka U, Abe I, Fujishima M. Troglitazone, an insulin sensitizer, increases forearm blood flow in humans. Am J Hypertens. 1998 Sep;11(9):1134-7.

Chen S, Noguchi Y, Izumida T, Tatebe J, Katayama S. A comparison of the hypotensive and hypoglycaemic actions of an angiotensin converting enzyme inhibitor, an AT1a antagonist and troglitazone. J Hypertens. 1996 Nov;14(11):1325-30.

Saku K, Zhang B, Ohta T, Arakawa K. Troglitazone lowers blood pressure and enhances insulin sensitivity in Watanabe heritable hyperlipidemic rabbits. Am J Hypertens. 1997 Sep;10(9 Pt 1):1027-33.

Nolan JJ, Ludvik B, Beerdsen P, Joyce M, Olefsky J. Improvement in glucose tolerance and insulin resistance in obese subjects treated with troglitazone. N Engl J Med. 1994 Nov 3;331(18):1188-93.

ClinicalTrials.gov Identifier:	NCT00290394 History of Changes
Other Study ID Numbers:	KA03/181
Study First Received:	February 9, 2006
Last Updated:	February 9, 2006
Health Authority:	Turkey: Ministry of Health

Keywords provided by Baskent University:

Blood Pressure,
rosiglitazone,Diabetes Mellitus, Type 2,

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013